Sunday, July 20, 2008

Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety

July 19, 2008, 5:44PM

Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety

By STEPHANIE STROM New York Times

For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of America's blood supply, it continues to fall short.

The situation has proved so frustrating that in January the commissioner of food and drugs attended a Red Cross board meeting — a first for a commissioner — and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting. They requested anonymity because Red Cross policy prohibits public discussion of its meetings with regulators.

"If fear is a motivator, we're happy to help out in that way," said Eric M. Blumberg, deputy general counsel at the Food and Drug Administration, though he declined to confirm what the commissioner, Andrew C. von Eschenbach, said at the meeting.

Some critics, including former Red Cross executives, have even suggested breaking off the blood services operations from the rest of the organization, as the Canadian Red Cross did a decade ago.

Recipients at risk

The problems, described in more than a dozen publicly available FDA reports — some of which cite hundreds of lapses — include shortcomings in screening donors for possible exposure to diseases; failures to spend enough time swabbing arms before inserting needles; failures to test for syphilis; and failures to discard deficient blood.

In some cases, the lapses have put the recipients of blood at risk for diseases like hepatitis, malaria and syphilis.

But according to the FDA, the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.

While many Americans see the Red Cross as the ubiquitous organization that responds to disasters big and small, its disaster-relief operation, which spends $400 million to $500 million annually, is small compared with its blood business, which generated $2.1 billion in revenue in the fiscal year that ended in June 2007.

The Red Cross, which controls 43 percent of the nation's blood supply, agrees that it has had quality-control problems and is working to fix them.

Both its officials and the drug agency point out that none of the identified problems involve the most serious category of infractions. For instance, the Red Cross now does a good job of testing for HIV and hepatitis B, officials on all sides agree. And in general, Red Cross blood is regarded as some of the safest in the world.

5 million transfusions

Still, the FDA says, the problems that remain in screening donors and following protocols for collection add unnecessary risk to blood transfusions, almost 5 million of which were done in 2007, according to the National Heart, Lung and Blood Institute.

"This is a critical piece of the public health infrastructure," said Mary A. Malarkey, director of the Office of Compliance and Biologics Quality at the FDA. "I know it's difficult to get so many people trained and properly supervised, but it has to be done."

In the last week, the FDA sent the Red Cross the results of yet another recent investigation that makes Malarkey's point: From December 2006 to April 2008, the Red Cross distributed more than 200 blood products that it had already identified as problematic, according to the investigation report.

Modest improvements

After years of quiet complaints about the Red Cross' blood business, the FDA reluctantly decided to go public with its concerns in 1993, obtaining a consent decree that required the Red Cross to strengthen quality control and training and improve its ability to identify, investigate and record problems.

"It was one of the hardest things I did as commissioner," said Dr. David A. Kessler, the FDA commissioner from 1990 to 1997. He said he agonized the move would cause undue alarm.

Fifteen years later, that consent decree, toughened in 2003 to allow the FDA to impose fines for failing to properly identify, handle and report quality control problems, has produced only modest improvements, food and drug officials said.

"Leaving aside who's at fault here, it's not working," said Kessler, now a professor of pediatric medicine at the University of California, San Francisco. "Whether it's that the American Red Cross just doesn't get it, whether it's that the relationship between the regulator and regulated is beyond the point of repair is immaterial."

Kessler said Congress should intervene at this point.

Dr. Bernadine Healy, the former chief executive of the Red Cross who made repairing the organization's blood operations a paramount goal, said the best solution might be to spin off blood services.

"Two-thirds of the revenue base of the Red Cross is blood, yet the Red Cross is run by people who think of it as primarily a disaster-relief organization, relegating blood to stepchild status," Healy said.

THIS was like closing the barn door after the mad cows got loose. not only the red cross, but the FDA has failed the public in protecting them from the TSE aka mad cow agent. TSE agent i.e. bse, base, cwd, scrapie, tme, and any sub strains thereof. we do not know if these strains will or have transmitted to humans as subclinical TSE or clinical disease, and we do not know if they have or will transmit second, third, forth passage via friendly fire i.e. multiple potential routes via medical, surgical, pharmaceutical etc.

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About Me

My mother was murdered by what I call corporate and political homicide i.e. FOR PROFIT! she died from a rare phenotype of CJD i.e. the Heidenhain Variant of Creutzfeldt Jakob Disease i.e. sporadic, simply meaning from unknown route and source. I have simply been trying to validate her death DOD 12/14/97 with the truth. There is a route, and there is a source. There are many here in the USA. WE must make CJD and all human TSE, of all age groups 'reportable' Nationally and Internationally, with a written CJD questionnaire asking real questions pertaining to route and source of this agent. Friendly fire has the potential to play a huge role in the continued transmission of this agent via the medical, dental, and surgical arena. We must not flounder any longer. ...TSS